Label: CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17% gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 17, 2019

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  • Directions for use

    aa

  • Sincerus Florida, LLC. Adverse reactions

    ds

  • Active, inactive

    sd

  • NDC 72934- 1047-2 CIMETIDINE USP 5% / IBUPROFEN USP 2% / SALICYLIC ACID USP 17%. Gel 30gm.

    sf

  • INGREDIENTS AND APPEARANCE
    CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17% 
    cimetidine 5% / ibuprofen 2% / salicylic acid 17% gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN2 g  in 100 g
    CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD) CIMETIDINE5 g  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID17 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-1047-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/17/2019
    Labeler - Sincerus Florida, LLC (080105003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sincerus Florida, LLC080105003manufacture(72934-1047)